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. 2022 Apr 4;23(1):251.
doi: 10.1186/s13063-022-06207-x.

Comparing Sugarbaker versus keyhole mesh technique for open retromuscular parastomal hernia repair: study protocol for a registry-based randomized controlled trial

Benjamin T Miller  1 , Jonah D Thomas  2 , Chao Tu  3 , Adele Costanzo  4 , Lucas R A Beffa  4 , David M Krpata  4 , Ajita S Prabhu  4 , Michael J Rosen  4 , Clayton C Petro  4
Affiliations

Comparing Sugarbaker versus keyhole mesh technique for open retromuscular parastomal hernia repair: study protocol for a registry-based randomized controlled trial

Benjamin T Miller et al. Trials. .

Abstract

Background: Parastomal hernia, common after stoma creation, negatively impacts patient quality of life. For patients with a permanent stoma, durable parastomal hernia repair remains a challenge, with few high-quality studies for guidance. An alternative to open retromuscular parastomal hernia repair with retromuscular "keyhole" mesh is the recent Sugarbaker modification. We aim to compare these two techniques in a head-to-head prospective study.

Methods: This is a registry-based randomized controlled trial designed to investigate whether the retromuscular Sugarbaker technique is superior to the retromuscular keyhole technique for parastomal hernia repair. The primary study endpoint is parastomal hernia recurrence at 2 years. Secondary endpoints include hospital length-of-stay, readmission, wound morbidity, mesh-related complications, re-operation, all 30-day morbidity, and patient-reported outcomes, including hernia-related quality of life, stoma-specific quality of life, pain, and decision regret.

Discussion: Based on the post hoc analysis of a recent randomized controlled trial, we hypothesize that the retromuscular Sugarbaker technique will reduce parastomal hernia recurrence by 20% at 2 years compared to the retromuscular keyhole mesh technique. The results of this study may provide evidence-based guidance for surgeons repairing parastomal hernias.

Trial registration: ClinicalTrials.gov NCT03972553. Registered on 3 June 2019.

Keywords: Keyhole; Parastomal hernia; Randomized controlled trial; Retromuscular; Sugarbaker; Transversus abdominis release.

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Conflict of interest statement

Ajita S Prabhu, MD, receives consulting fees from Verb Surgical and CMR Surgical and speaking fees and a research grant (paid to the Cleveland Clinic Foundation) from Intuitive Surgical.

Michael J Rosen, MD, receives salary support as Medical Director of ACHQC and is an Ariste Medical board member with stock options.

Clayton C Petro, MD, received a $20,000 Central Surgical Association grant for this trial.

The other authors declare that they have no competing interests.

Figures

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Fig. 1
Participant timeline
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References

    1. Carne PW, Robertson GM, Frizelle FA. Parastomal hernia. Br J Surg. 2003;90(7):784–793. doi: 10.1002/bjs.4220. - DOI - PubMed
    1. Hotouras A, Murphy J, Thaha M, Chan L. The persistent challenge of parastomal herniation: A review of the literature and future developments. Color Dis. 2013;15(5):202–214. doi: 10.1111/codi.12156. - DOI - PubMed
    1. Husain SG, Cataldo TE. Late stomal complications. Clin Colon Rectal Surg. 2008;21(1):31–40. doi: 10.1055/s-2008-1055319. - DOI - PMC - PubMed
    1. Kald A, Juul KN, Hjortsvang H, Sjodahl RI. Quality of life is impaired in patients with peristomal bulging of a sigmoid colostomy. Scand J Gastroenterol. 2008;43(5):627–633. doi: 10.1080/00365520701858470. - DOI - PubMed
    1. Turnbull GB. Ostomy statistics: The $64,000 question. Ostomy Wound Manage. 2003;49(6):22–23. - PubMed

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